Extended Phenytoin Sodium

Product NDC
72162-2514
11-digit product format
721622514
Labeler code
72162
Product ID
72162-2514_374e2998-0c04-c804-e063-6394a90a67c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204309
Marketing category
ANDA
Marketing start
2015-06-10
Substance
PHENYTOIN SODIUM
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4182431BJHPHENYTOIN SODIUM630-93-3PHENYTOIN SODIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2514-0721622514001000 CAPSULE in 1 BOTTLE (72162-2514-0) 1000 capsule2025-06-09NoNoHistorical
72162-2514-172162251401100 CAPSULE in 1 BOTTLE (72162-2514-1) 100 capsule2025-06-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Extended Phenytoin SodiumBryant Ranch Prepack2025-06-11HUMAN PRESCRIPTION DRUG LABEL100